Virtual Hypertension Clinic (VHC)

October 26, 2016 updated by: The Cleveland Clinic

Virtual Hypertension Clinic (VHC) Study

This is a prospective, randomized controlled trial designed to determine whether blue tooth and telephone technology can be utilized to successfully relaying home blood pressure information electronically to healthcare providers so that timely and more frequent treatment interventions can be instituted to optimize and reach goal blood pressure level for an individual as compared to usual care. The primary study outcomes are improvement in systolic, diastolic, and blood pressure control and time to control blood pressure. Secondary outcomes are proportion of patients controlled to blood pressure goal at the end of the study, adherence to blood pressure monitoring and utilization of VHC model.

If this is successful and cost-effective such technology and interventions could be utilized on large scale to improve the care and proportion of hypertensive patients achieving goal blood pressure in the United States.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hypertension is a major risk factor for renal and cardiovascular disease, and a significant contributor to adult disability. About 50 million individuals are hypertensive in the United States1. The Framingham Heart Study suggests that normotensive individuals at 55 years have a 90% lifetime risk of hypertension2. Treatment of hypertension is the leading reason for physician visits and prescription drugs in the US3. Despite increasing awareness of the risks and of complications of poorly controlled hypertension, only 58% of hypertensive patients are being treated and of these only 38% achieve blood pressure control4, 5. Sub-optimal therapy remains the most common cause for uncontrolled hypertension6. One of the major barriers to effective management of hypertension is therapeutic inertia on the part of physicians that leads to suboptimal therapy being prescribed for hypertensive patients7.

This barrier to effective hypertension treatment achieves further significance as data from several clinical trials clearly demonstrate that reduction of blood pressure by even a few millimeters of mercury can significantly decrease an individual risk for mortality from cardiovascular disease8.

Although hypertension remains the most common reason for patient visit to a physician office in the United States, the lack of patient-health care provider connectivity outside the office setting may play an important factor in the disappointing proportion of patients achieving blood pressure control in the US for the past 30 years.

Recent home blood pressure monitoring guidelines published by the American Heart Association and other professional societies have emphasized the importance of home blood pressure monitoring in the management of hypertension9. In addition, a recent study by Green et al extended this concept a step further by utilizing a web based intervention utilized by a pharmacist to control blood pressure10. Results from this study they demonstrated a significant reduction in blood pressure in the intervention group when compared to usual care (-14.2 mmHg Vs -5.3 mmHg p <0.001).

One of the potential draw backs of a web based intervention for blood pressure control could be the lack of access to internet in the general population. According to a recent USDA report, almost 40% Americans in urban areas and 60% in rural areas do not have internet access (http://arstechnica.com/tech-policy/news/2009/03/the-many-blessing-of-rural.ars ). This in essence would deprive a large number of those with hypertension from access to the web based newer models of blood pressure control as tested in the recent study by Green et al.

The Stabil-o-Graph is a validated home blood pressure device (http://www.dableducational.org/dabl_library/library2_sbpm.html#upper_arm) that relays blood pressure readings to a designated health care provider using blue tooth technology and a telephone connection

The current model of health care in the US for the management of hypertension employs direct patient-physician encounters in an office setting to control blood pressure. This existing healthcare model has failed to keep abreast with current national guidelines and consensus among experts in hypertension that promote home blood pressure monitoring and application of newer technology with the potential to seamlessly connect a patient with his health care provider with the goal of improved blood pressure control.

Our proposed study aims to address this gap in patient-healthcare provider connectivity utilizing newer technology and home blood pressure monitoring to achieve goal blood pressure foe an individual.

Study Type

Interventional

Enrollment (Anticipated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 25-65 years with essential hypertension
  • Poorly controlled Hypertension (Systolic BP 140-199 Diastolic BP 90-110 mmHg

Exclusion Criteria:

  • Patient on 4 or more antihypertensive medications
  • History of non compliance with medications
  • If extra-large cuff cannot fit the arm
  • Patient with estimated glomerular filtration of less than 30 ml/min in the past two years)
  • Patients with acute glomerulonephritis
  • Patient with secondary hypertension
  • Patient with severe congestive heart failure (New York Heart Association Functional Classification Class III AND IV)
  • Patient with cirrhosis
  • Patients with terminal diseases like cancers (other than non-melanoma skin cancers)
  • Excessive alcohol intake (> 7 servings/week)
  • Sensitivity or contra-indications to the use of 2 or more classes of antihypertensive medications
  • Women who are pregnant (self reported) or lactating
  • Women on oral contraceptive pills

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Virtual Hypertension Clinic Group
In the VHC group, patients will be ask to regularly measure blood pressure with the Stabil-o-Graph so that these readings are transmitted to Virtual Hypertension Clinic. The data will be reviewed weekly and the patient will receive feedback and intervention if needed at every 2 week interval to achieve blood pressure goal. Once they reach goal, the feedback will be less intense and given at four week intervals till the end of the study.
Other: Virtual Hypertension Clinic
In the VHC group, patients will be ask to regularly measure blood pressure with the Stabil-o-Graph so that these readings are transmitted to Virtual Hypertension Clinic. The data will be reviewed weekly and the patient will receive feedback and intervention if needed at every 2 week interval to achieve blood pressure goal. Once they reach goal, the feedback will be less intense and given at four week intervals until the end of the study.
Other Names:
  • Diuretics
  • Vasodilators
  • ACE Inhibitors
  • Angiotensin II Receptors
  • Calcium Channel Blockers
  • Renin Inhibitors
  • BetaBlockers
  • AlphaBlockers
No Intervention: Usual Care Group
The Usual Care Group (UCG) patients will be told their BP is not in control and encouraged to work with their physician to improve it. There will be no further structured intervention during the rest of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in home diastolic, systolic, and mean arterial blood pressure
Time Frame: week 0 (screening) and week 15(final week)
BP taken at home twice a day (morning and evening) Comparison of the average of the screening week's (Week 0)home blood pressure measurements with the average of the final week's (Week 15) home blood pressure measurements for each participant. Mean arterial blood pressure measurement values obtained at Clinic Visit One and Clinic Visit Two will be compared
week 0 (screening) and week 15(final week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion at the end of the study of participants in each group with controlled hypertension based on average home diastolic and systolic blood pressures transmitted by Stabil-o-Graph (averaged over each 2 week interval during the study period).
Time Frame: Week 0(screening) and Week 15 (final)
Comparison of the average of the screening week's (Week 0)home blood pressure measurements with the average of the final week's (Week 15) home blood pressure measurements for each participant.
Week 0(screening) and Week 15 (final)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Mohammed Rafey, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (Estimate)

July 22, 2010

Study Record Updates

Last Update Posted (Estimate)

October 28, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-575

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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